Why you should not start clinical trials on your own, and need SMO ?

Why you should not start clinical trials on your own, and need SMO ?

The significance of a Site Management Organization (SMO) is to entice more pharmaceutical corporations to outsource their clinical trials to India. SMOs aims to provide cost-effective clinical trial conduct. It is a company that specializes in running clinical research sites, as implied by the name “site management organization.”

SMOs typically oversee and collaborate closely with a network of clinical research locations. Based on their understanding and agreement with the head of the clinical research site, which may be a hospital or a private practice, SMOs may manage all or a portion of clinical research activity at a clinical research site.

Contract research organizations (CROs), pharmaceutical, biotechnology, medical device, and even clinical research sites use SMOs as service providers. According to recent projections from market research company R&D Directions, the estimated value of this emerging SMO market is now estimated to be over $3 billion.

Services provided by SMO:
Project feasibility
Investigator selection
Document submission for Institutional Review Board or Independent Ethics Committee (IRB/IEC) approval
Patient counselling
Patient recruitment
Patient follow-up
Informed consent form (ICF) translation into vernacular languages, etc.

By utilising site management organisations, patient recruitment takes much less time, and patient compliance is improved throughout the trial as a result of the efficient follow-up provided by SMO personnel stationed at clinical research sites. These goals are accomplished, thanks to the SMO’s strong relationships with local hospitals and researchers, which pharmaceutical corporations and some CROs lack.

SMO also offers its services to hospitals and investigators. At the location, the primary tasks are patient identification and recruitment. SMO assists with patient recruitment in accordance with the study protocol and ensures that participants are aware of the study’s protocols, including visit schedules and laboratory processes. SMO also assists the site with all documentation-related tasks, such as constantly updating the site files, maintaining study-specific logs (such as a temperature log or a drug accountability log), maintaining patient diaries, and storing the drugs in accordance with protocol, submitting paperwork to the ethics committee, etc.

Utilizing an SMO can also free up the investigator to focus on patient recruiting, lessening their workload and the sponsor’s financial and time commitment. For sponsor businesses and CROs starting multicentric clinical trials, SMO can be a time and money saver.

The benefits of outsourcing a trial to SMO are rapid patient recruitment, accurate and consistent documentation, reduced study timelines due to quicker study start-up, more accurate doctor contact information, reduced site management time, improved relationships with investigators, and cost effective.”

Since an SMO will effectively and efficiently reduce their burden, outsourcing a clinical trial to one can be a tremendous assistance to the global pharmaceutical sector in terms of establishing their business in India as well as globally. In addition to having a sizable network of clinical trial sites, the contract research business Medigence Solutions can also offer reliable site administration solutions.

Benefits of a Site Management Organization (SMO)

A novel treatment’s development must go through the crucial phase of clinical trials. The outcomes of this study could be the difference between a new therapy receiving regulatory approval and becoming widely used or not.

The operational complexity of this step in the process cannot be overstated. The enrolment of suitable patients, adhering to stringent regulatory requirements, and handling enormous amounts of data are just a few of the difficulties clinical research teams must overcome while working swiftly to meet deadlines.

Due to their complexity, 80 percent of clinical trials take longer than expected to complete—at least one to six months—while only 10 percent of trials are completed on time.

The operational burden can be handled by specialist providers, allowing the research team to concentrate on their trials. This is how many clinical research teams have had success. A site management company is one such supplier (SMO).

Related articles